Unique ID issued by UMIN | UMIN000025108 |
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Receipt number | R000028863 |
Scientific Title | Multi-institutional observational study for the efficacy and safety of Carfilzomib for multiple myeloma in Kyoto Clinical Hematology Study Group (KOTOSG) |
Date of disclosure of the study information | 2016/12/01 |
Last modified on | 2022/06/06 16:43:50 |
Multi-institutional observational study for the efficacy and safety of Carfilzomib for multiple myeloma in Kyoto Clinical Hematology Study Group (KOTOSG)
KOTOSG-CFZ observational study
Multi-institutional observational study for the efficacy and safety of Carfilzomib for multiple myeloma in Kyoto Clinical Hematology Study Group (KOTOSG)
KOTOSG-CFZ observational study
Japan |
Multiple myeloma
Hematology and clinical oncology |
Malignancy
NO
The purpose of this study is to reveal the efficacy and the safety of Carfilzomib in the real-world practice in Japan by the Kyoto Clinical Hematology Study Group (KOTOSG) multi-instituitional observational analyses of patients' background, the content of Carfilzomib-included therapy, therapeutic outcome and efficacy, and safety including adverse events.
Safety,Efficacy
Efficacy of Carfilzomib-containing therapy for multiple myeloma
Observational
20 | years-old | <= |
99 | years-old | >= |
Male and Female
Patients between 20 and 99 years old who received Carfilzomib-containing therapy
Patients who reject the enrollment in the study.
50
1st name | JUNYA |
Middle name | |
Last name | KURODA |
Kyoto Prefectural University of Medicine
Division of Hamatology and Oncology
602-8566
465 Kajii-cho, Kamigyo-ku, Kyoto, Japan
075-251-5740
junkuro@koto.kpu-m.ac.jp
1st name | JUNYA |
Middle name | |
Last name | KURODA |
Kyoto Prefectural University of Medicine
Division of Hamatology and Oncology
6028566
465 Kajii-cho, Kamigyo-ku, Kyoto, Japan
075-251-5740
junkuro@koto.kpu-m.ac.jp
Kyoto Prefectural University of Medicine
Ono Pharmaceutical Co.Ltd.
Profit organization
Kyoto Prefectural University of Medicine Ethical Review Board form Medical research
465 Kajii-cho, Kamigyo-ku, Kyoto, Japan
075-251-5337
rinri@koto.kpu-m.ac.jp
NO
京都府立医科大学附属病院、京都第一赤十字病院、京都第二赤十字病院、京都鞍馬口医療センター、愛生会山科病院、福知山市民病院(いずれも京都府)、松下記念病院(大阪府)、近江八幡総合医療センター、大津市民病院(滋賀県)
2016 | Year | 12 | Month | 01 | Day |
Published
50
2022 | Year | 02 | Month | 05 | Day |
Completed
2017 | Year | 05 | Month | 09 | Day |
2017 | Year | 05 | Month | 09 | Day |
2017 | Year | 06 | Month | 26 | Day |
2022 | Year | 03 | Month | 31 | Day |
2022 | Year | 06 | Month | 06 | Day |
2022 | Year | 06 | Month | 06 | Day |
2022 | Year | 06 | Month | 06 | Day |
Observation items in this study are listed as follows.
1 Bone marrow analysis
all nucleated cell count, myeloma cell ratio
2 Blood examination
complete blood cell count, LDH, AST, ALT, ALP, BUN, Cre, Na, K, Ca, IP, UA, CRP, beta-2-microglobulin, BNP(or NT-proBNP),immunoglobulin, serum free light chain, KL-6, PT, APTT, Fibrinogen, FDP, etc.
3 Urinary test
4 Radiologic examinations
Chest X-ray, Abdominal X-ray, CT, Cardiac ultrasonography, etc.
5 Physical examination
6 Adverse events evaluated by CTCAE v.4.0.
2016 | Year | 12 | Month | 01 | Day |
2022 | Year | 06 | Month | 06 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028863
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